No clinical signs or evidence of active brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 50-100%

Life expectancy:

At least 4 months

Hematopoietic:

Neutrophil count at least 1,500/mm3

Platelet count at least 100,000/mm3

Hemoglobin at least 10 g/dL

Hepatic:

Albumin at least 3.5 g/dL

Bilirubin less than 2.0 mg/dL

Transaminases no greater than 2.5 times upper limit of normal

Renal:

Creatinine no greater than 2.0 mg/dL

Creatinine clearance at least 60 mL/min

Cardiovascular:

No acute changes on EKG

No uncontrolled angina

No heart failure

No arrhythmia

Other:

Adequate nutritional intake as evidenced by total protein at least 60 g/L

Not pregnant or nursing

Fertile patients must use effective contraception

No concurrent gastrointestinal bleed

No active bacterial infections such as abscess or with fistulae

HIV negative

No other concurrent non-malignant disease that would preclude study

No history of alcoholism, drug addiction, or psychotic disorders that would preclude follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

More than 4 weeks since prior immunotherapy

More than 4 weeks since prior cytokines

More than 4 weeks since prior plasmapheresis or plasma exchange

No prior stem cell or bone marrow transplant

Chemotherapy:

More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)

No prior intensive chemotherapy with stem cell support

Endocrine therapy:

More than 4 weeks since prior corticosteroids

No concurrent corticosteroids

Radiotherapy:

More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow

Surgery:

Recovered from any prior surgery

No prior organ transplant

Other:

No other concurrent investigational agent

No concurrent immunosuppressants

No concurrent anti-inflammatory agents including aspirin and non-steroidal anti-inflammatory agents

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041379